College of Acupuncture, Moxibustion and Tuina, Henan University of Chinese Medicine, Zhengzhou, China.
Rehabilitation Medicine College Henan University of Chinese Medicine, Zhengzhou, China.
Front Public Health. 2024 Oct 16;12:1420299. doi: 10.3389/fpubh.2024.1420299. eCollection 2024.
Generalized anxiety disorder (GAD) is a common mental disorder that often begins in adolescence or early adulthood and is characterized by widespread and persistent anxiety. Partial sleep deprivation (PSD) is an important risk factor for GAD development and a common comorbidity. Adolescence is a period of rapid brain and nervous system development, and during this time, the occurrence of GAD can lead to neurocognitive deficits, such as impaired attention, cognitive control, and attention bias, that significantly affect cognitive function. However, relatively little research has been conducted on GAD comorbid with PSD in early adulthood compared with other psychiatric disorders. Clinical studies have demonstrated the effectiveness of acupuncture in treating GAD and sleep disorders, but the mechanism of how acupuncture modulates neurocognitive processing in patients with GAD comorbid with PSD has not been clarified.
METHODS/DESIGN: In this randomized clinical trial, a total of 56 participants diagnosed with GAD comorbid with naturally occurring PSD and 28 healthy controls (HCs) will be recruited. The participants diagnosed with GAD comorbid with PSD will be randomly assigned to either the acupuncture group or the sham acupuncture group at a 1:1 ratio. The primary outcome measure is the Hamilton Anxiety Rating Scale (HAMA). Secondary outcome measures are the Sleep Deprivation Index (SDI), the Self-Assessment Scale for Anxiety (SAS), the Epworth Sleepiness Scale (ESS), and the State-Trait Anxiety Inventory (STAI). Additionally, three psychological paradigms (the attentional network test, psychomotor vigilance test, and emotional face Go/No-go) and event-related potential (ERP) data. Healthy volunteers will not undergo acupuncture but will instead participate in baseline assessments for the scales, mental paradigms, and ERP data. Acupuncture and sham acupuncture interventions will be conducted for 30 min, three times a week, over a 2-week period. Evaluations will be performed at zero weeks (baseline), 1 week, and 2 weeks, with the data enumerator, outcome assessor, and participant blinded to the treatment assignment.
This study contributes to the exploration of the effects of acupuncture on improving anxiety symptoms and cognitive functions in individuals with comorbid GAD and PSD.
ClinicalTrials.gov, ChiCTR2400082221. Registered March 25, 2024.
广泛性焦虑障碍（GAD）是一种常见的精神障碍，通常在青少年或成年早期开始，其特征是广泛而持续的焦虑。部分睡眠剥夺（PSD）是 GAD 发展的重要危险因素，也是常见的合并症。青春期是大脑和神经系统快速发育的时期，在此期间，GAD 的发生会导致神经认知缺陷，如注意力受损、认知控制和注意力偏差，这会显著影响认知功能。然而，与其他精神障碍相比，针对成年早期 GAD 合并 PSD 的研究相对较少。临床研究表明针灸治疗 GAD 和睡眠障碍有效，但针灸如何调节 GAD 合并 PSD 患者的神经认知处理机制尚未阐明。
方法/设计：在这项随机临床试验中，将招募 56 名被诊断为 GAD 合并自然发生 PSD 的患者和 28 名健康对照者（HCs）。被诊断为 GAD 合并 PSD 的患者将以 1:1 的比例随机分配到针灸组或假针灸组。主要结局测量指标是汉密尔顿焦虑量表（HAMA）。次要结局测量指标是睡眠剥夺指数（SDI）、焦虑自评量表（SAS）、Epworth 嗜睡量表（ESS）和状态-特质焦虑量表（STAI）。此外，还将进行三种心理范式（注意网络测试、精神运动警觉测试和情绪面孔 Go/No-go）和事件相关电位（ERP）数据。健康志愿者不会接受针灸治疗，而是将参加量表、心理范式和 ERP 数据的基线评估。针灸和假针灸干预将在两周内每周进行三次，每次 30 分钟。评估将在零周（基线）、1 周和 2 周进行，数据计数员、结果评估者和参与者对治疗分配不知情。
这项研究有助于探索针灸对改善 GAD 和 PSD 合并症患者焦虑症状和认知功能的影响。
ClinicalTrials.gov，ChiCTR2400082221。注册于 2024 年 3 月 25 日。
